Trial Information
Protocol for the Specified Clinical Experience Investigation on the Single Use of Casodex® Tablet 80 mg
Inclusion Criteria:
- Prostate cancer patients who have no history of receiving endocrine therapy
(including surgical castration), and who plan to undergo Casodex® tablets monotherapy
for not less than 12 months
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Adverse event incidence
Outcome Time Frame:
Time since starting Casodex monotherapy, monthly
Safety Issue:
Yes
Authority:
Japan: Institutional Review Board
Study ID:
NIS-OJP-CAS-2009/1
NCT ID:
NCT00919477
Start Date:
May 2009
Completion Date:
March 2012
Related Keywords:
- Prostate Cancer
- Prostate cancer
- Casodex
- Monotherapy
- Prostatic Neoplasms